Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT06285695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2024-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clareon Toric Study (T2-T9)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001035', 'term': 'Aphakia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-02-23', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean monocular best corrected distance visual acuity (BCDVA)', 'timeFrame': 'Month 6, Year 1, Year 3 (post implantation)', 'description': 'Visual acuity will be assessed for each eye individually using letter charts and recorded in logarithm minimum angle of resolution (logMAR).'}], 'secondaryOutcomes': [{'measure': 'Mean monocular absolute residual refractive cylinder', 'timeFrame': 'Month 3, Month 6, Year 1, Year 3 (post implantation)', 'description': 'The amount of residual astigmatism will be assessed for each eye individually using letter charts and recorded in diopters.'}, {'measure': 'Mean absolute IOL rotation from previous visit', 'timeFrame': 'Month 1 to Month 3, Month 3 to Month 6, Month 6 to Year 1, Year 1 to Year 3 (post implantation)', 'description': 'The difference in IOL axis of orientation from the previous visit will be assessed by a reading center and recorded in degrees.'}, {'measure': 'Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit', 'timeFrame': 'Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Year 1, Year 3 (post implantation)', 'description': 'The difference in IOL axis of orientation from baseline (end of surgery, patient laying flat) will be assessed by a reading center and recorded in degrees.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aphakia', 'Corneal Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).', 'detailedDescription': 'Subjects will attend up to 12 scheduled visits (one preoperative visit, up to two surgical visits, and up to 9 postoperative visits) over the course of the study (3 years follow-up). The overall study duration is expected to be approximately 4 years. This study will be conducted in Canada.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Able to understand and sign the informed consent form.\n* Willing and able to attend all scheduled study visits as required per protocol.\n* Cataract in one or both eyes with planned extraction by conventional phacoemulsification.\n* Astigmatism in the operative eye(s).\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Women of childbearing potential, currently pregnant, intend to become pregnant during the study, or nursing.\n* History of retinal detachment, age-related macular degeneration, glaucoma, diabetic retinopathy, or any pathologic changes associated with the optic nerve.\n* Clinically significant corneal disease that may, according to the Investigator's medical opinion, adversely affect visual outcomes.\n* Clinically significant dry eye that would affect study measurements based on the Investigator's expert medical opinion.\n* History of prior intraocular or corneal surgery.\n* Other protocol-defined exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT06285695', 'briefTitle': 'Clareon Toric Study (T2-T9)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clareon Toric Single Arm Study (T2-T9)', 'orgStudyIdInfo': {'id': 'ILS241-I001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clareon Toric IOL', 'description': 'Clareon Toric IOL implanted in one or both eyes during cataract surgery', 'interventionNames': ['Device: Clareon Toric IOL', 'Procedure: Cataract surgery']}], 'interventions': [{'name': 'Clareon Toric IOL', 'type': 'DEVICE', 'otherNames': ['Models CNW0T2, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8, CNW0T9, CNA0T2, CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8, CNA0T9'], 'description': 'Aspheric hydrophobic acrylic IOL placed in the capsular bag in the posterior chamber of the eye during cataract surgery for the visual correction of aphakia and preexisting corneal astigmatism', 'armGroupLabels': ['Clareon Toric IOL']}, {'name': 'Cataract surgery', 'type': 'PROCEDURE', 'description': 'Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL', 'armGroupLabels': ['Clareon Toric IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 0M3', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Gimbel Eye Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'L4K 2Z5', 'city': 'Concord', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Uptown Eye Specialists', 'geoPoint': {'lat': 43.80011, 'lon': -79.48291}}, {'zip': 'L6H 0J8', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Prism Eye Institute', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'J7H 0E8', 'city': 'Boisbriand', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Laurentians Eye Institute', 'geoPoint': {'lat': 45.61678, 'lon': -73.83249}}, {'zip': 'H1V 1G5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Bellevue', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'R7A 3N2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Clinical Trial Management Operations, Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}